## Facts

- The United States, through the FDA and DOJ, sued Barr Laboratories, a generic drug manufacturer, alleging violations of the Federal Food, Drug, and Cosmetic Act (FDCA) and current good manufacturing practices (cGMPs).
- The government alleged Barr’s methods, facilities, and controls did not conform to cGMPs, causing drug products manufactured and distributed by Barr to be “adulterated” under the FDCA.
- FDA inspections repeatedly documented deficiencies through inspectional observations and related communications, culminating in an enforcement action seeking to halt manufacturing and distribution absent compliance.
- After transfer to the District of New Jersey and consolidation with related litigation, the court held a lengthy evidentiary hearing with extensive testimony and documentary evidence.
- The court found recurring laboratory and manufacturing control failures, including inadequate investigations of failed test results, heavy reliance on retesting and resampling after failures, and release decisions based on selective or non-representative data.
- The court found deficiencies in validation and quality controls, including method validation problems, retrospective validation practices that excluded failing results or batches, and inadequate blend testing procedures.
- The court also found related cGMP failures such as cleaning validation shortcomings, recordkeeping defects affecting traceability, and regulatory-reporting noncompliance (including failures to submit required ANDA supplements and field alerts).
- Barr contended its practices were consistent with industry norms, argued FDA expectations were overly strict or shifting, and asserted it had implemented remedial measures; the court found many changes reactive and incomplete given the history of violations.

## Issues

1. Whether Barr’s manufacturing and laboratory practices violated cGMP requirements so as to render its drug products “adulterated” under the FDCA.
2. Whether the United States met the requirements for a preliminary injunction restraining manufacturing and distribution until cGMP compliance could be demonstrated.

## Decision

- The court found the United States was likely to succeed on the merits that Barr failed to comply with cGMPs and distributed adulterated drugs within the meaning of the FDCA.
- The court determined that systemic cGMP noncompliance posed a sufficient risk to public health to constitute irreparable harm, and that the public interest favored immediate judicial intervention.
- The court granted a preliminary injunction imposing detailed conditions and oversight, restricting Barr’s manufacturing and distribution unless and until compliance was shown to the FDA and the court.
- The court concluded Barr’s asserted corrective actions did not eliminate the likelihood of future violations given the recurring nature and breadth of the deficiencies.

## Legal Principles

- Under the FDCA, a drug is “adulterated” if the methods, facilities, or controls used in manufacturing, processing, packing, or holding do not conform to cGMP requirements.
- The government need not prove actual consumer injury from a specific batch to establish adulteration where persistent cGMP violations show inadequate systems for assuring identity, strength, quality, and purity.
- cGMP requires scientifically sound investigation of test failures and out-of-specification results; retesting, resampling, and averaging cannot substitute for adequate root-cause inquiry or be used to disregard unfavorable data without justification.
- Persistent, systemic quality-system deficiencies support injunctive relief to prevent continued distribution of potentially nonconforming drugs and to protect the public interest.
- In evaluating preliminary injunctive relief in FDCA enforcement, strong evidence of recurring regulatory violations and ongoing risk to public health can outweigh the defendant’s claimed operational burdens and partial remediation.

## Conclusion

The court granted preliminary injunctive relief because Barr’s recurrent cGMP noncompliance rendered its drugs adulterated under the FDCA and created an ongoing risk to public health, warranting court-supervised restrictions until compliance was established.


United States v. Barr Labs., Inc., 812 F. Supp. 458 (D.N.J. 1993)